Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease
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|ClinicalTrials.gov Identifier: NCT01540032|
Recruitment Status : Unknown
Verified February 2012 by Hamilton Health Sciences Corporation.
Recruitment status was: Not yet recruiting
First Posted : February 28, 2012
Last Update Posted : February 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Aspirin Exacerbated Respiratory Disease Samter's Triad||Behavioral: Low salicylate diet Behavioral: Normal diet||Not Applicable|
Aspirin-exacerbated respiratory disease (AERD) is clinically diagnosed in patients who suffer from allergy to aspirin, asthma, nasal polyps, and chronic sinusitis. Patients with AERD are often resistant to medical management of nasal polyps, and require multiple endoscopic sinus surgeries to manage recurrences of nasal polyps. Control of AERD can be obtained through aspirin desensitization, which consists of taking aspirin every day. However, there are substantial risks and adverse side effects to taking moderate amounts of aspirin daily. Furthermore, patients experience progressively worsening nasal and respiratory disease even with complete avoidance of aspirin and other NSAIDs.
The active and major component in aspirin/NSAIDs is salicylate, which is also found naturally in some foods. Diet modification is a cost-effective intervention that has the potential to provide long-term remission of AERD. Our study will evaluate whether a low salicylate diet, which is a more cost effective and benign intervention with minimal risks, will improve nasal, sinus or respiratory symptoms, such as congestion, sinusitis, smell, or asthma.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||February 2013|
|No Intervention: Control||
Behavioral: Normal diet
Patients will eat their usual diet.
Behavioral: Low salicylate diet
Patients will avoid foods from the 'high salicylate' group completely. They can eat foods from the 'low salicylate' group freely and just eat foods from the medium group occasionally, and not in large amounts.
- Change in SNOT-22 scores from Baseline [ Time Frame: 6 weeks and 12 weeks ]As this is a crossover study, all participants will complete the SNOT-22 questionnaire at the beginning of the study. After 6 weeks of their assigned diet (normal vs low salicylate), they will complete the SNOT-22 questionnaire to see if there are any differences in subjective nasal and sinus symptoms. After 6 weeks, the participants cross over to the other diet and they will complete the SNOT-22 questionnaire again in another 6 weeks when the study ends.
- Change in Lund-Kennedy Endoscopic Score from Baseline [ Time Frame: 6 weeks and 12 weeks ]As this is a crossover study, all participants will be evaluated for the Lund-Kennedy Endoscopic Score at the beginning of the study. After 6 weeks of their assigned diet (normal vs low salicylate), they will be re-evaluated in clinic to see if there are any differences in endoscopy findings. After 6 weeks, the participants cross over to the other diet and they will have a final endoscopic evaluation in another 6 weeks when the study ends.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540032
|Contact: Doron Sommer, MD||905-521-2100 ext firstname.lastname@example.org|
|Hamilton Health Sciences||Not yet recruiting|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator: Doron Sommer, MD|
|St. Joseph's Health Care||Not yet recruiting|
|London, Ontario, Canada, N6A 4V2|
|Principal Investigator: Brian Rotenberg, MD|
|St. Michael's Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5B 1W8|
|Principal Investigator: John Lee, MD|
|Mount Sinai Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator: Allan Vescan, MD|